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Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia

Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia - Phase II study of carboplatin plus weekly paclitaxel for advanced squamous cell lung cancer with idiopathic interstitial pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018248
Enrollment
40
Registered
2015-07-09
Start date
2012-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced squamous cell lung cancer with idiopathic interstitial pneumonia

Interventions

Carboplatin AUC = 5 , day1 Paclitaxel 70mg/m2, day1,8,15 4-6 cycle

Sponsors

IP lung cancer study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Squamous cell lung cancer 2) Age over twenty 3) Idiopathic interstitial pneumonia 4) Measurable lesion 5) ECOG performance status 0 or 1 6) Adequate organ function WBC>=3000/mm3 and neutrophil count >=2000/mm3 Hgb>=10.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL 7) PaO2>=60.0 torr or SpO2>=92.0 %( room air) 8) No symptoms from brain metastasis 9) Life expectancy > 3 months 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Secondly interstitial pneumonia. 2) History of acute exacerbation of interstitial pneumonia within 3 months. 3) Subacute progression of interstitial pneumonia within 3 months. 4) Using prednisolone or immune-suppressive agent. 5) Need to home oxygen therapy. 6) Past history of severe drug allergy. 7) Active infectious disease. 8) Severe complications 9) Symptomatic brain metastasis. 10) Uncontrollable effusion. 11) Active combined malignancy 12) Any ineligible case judged by physician.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
OS: overall survival PFS: progression free survival TTF: Time to treatment failure toxicity

Countries

Japan

Contacts

Public ContactHidekazu Suzuki

Osaka Preferctural Medical Center for Respiratory and Allegic Diseases Thoracic Oncology

suzukih@opho.jp072-957-2121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026